ZIPwire™ M00146165B0Recalls & reported problems
Lake Region Medical · Class 2
All models of ZIPwire (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729763987), received between Jul 19, 2023 and Jul 19, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Damaged by Another Device1
- Material Split, Cut or Torn1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2023Device Damaged by Another Device; Material Split, Cut or Torn; Device Damaged by Another Device; Material Split, Cut or Torn
EVENT DESCRIPTION: IT WAS REPORTED THAT: ON THE AFTERNOON OF (B)(6) 2023 IN OPERATING ROOM 18 THEY WERE PERFORMING A NEPHROSTOMY AND THEY USED THIS DEVICE, LEAVING A LONGITUDINAL THREAD INSIDE THE PATIENT WHEN REMOVING THE GUIDE WIRE ADDITIONAL INFORMATION RECEIVED JULY 11, 2023: 1. PER EVENT, "LEAVING A LONGITUDINAL THREAD INSIDE THE PATIENT WHEN REMOVING THE GUIDE WIRE". PLEASE FURTHER CLARIFY. -THAT'S THE ONLY INFORMATION THAT WE HAVE. 2. PLEASE FURTHER DESCRIBE THE DECISION TO LEAVE THE DETACHED COMPONENT IN THE PATIENT. (IT IS UNCLEAR IF SNARING ATTEMPTS WERE UNSUCCESSFUL, THE DEVICE MIGRATED POST DETACHMENT, IS LODGED IN AN UNREACHABLE LOCATION, ETC). PLEASE BE SPECIFIC. -IT WAS NOT A DECISION, IT WAS AN ISSUE OF THE GUIDEWIRE THAT BROKE INSIDE OF THE PATIENT AND DUE TO THIS, THEY CAN'T RECOUP THE BROKEN PART LEFT THERE. 3. HOW WAS THE DEVICE REMOVED (I.E SNARING, OTHER RETRIEVAL DEVICES OR INVASIVE TECHNIQUES OR WAS IT SIMPLY REMOVED AS A WHOLE ALL TOGETHER)? LIKE USUALLY. 4. WHAT IS THE CURRENT CONDITION OF THE PATIENT? STABLIZED. 5. HOW WAS THE PROCEDURE COMPLETED? (WITH ANOTHER OF THE SAME DEVICE, WITH A DIFFERENT DEVICE, RESCHEDULED, OR POSTPONED.) DON'T KNOW. 6. PER FDA
Patient problems: Foreign Body In Patient
MAUDE report 17349972 ↗
Other Wire, Guide, Catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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